Court declares nutraceutical prior-approval advisory ‘unlawful’

Dietary and health supplement manufacturers in India will be breathing a sigh of relief after a decision by the Bombay High Court to quash a controversial advisory by the country’s food regulator concerning prior product approvals.

The Indian Drug Manufacturers Association and a private nutraceutical firm had moved the High Court last year to challenge the advisory by the Food Safety and Standards Authority of India (FSSAI) to require prior product approvals of dietary food and health supplements already licenced and existing in the market under the former Food Adulteration Act.

FSSAI move unjustified

The plaintiffs said the authority had no powers to issue the advisory, especially as the Food Safety and Standards Act has been governing manufactured food safety in India since 2006.

Speaking to Food & Beverage News, RK Sanghavi of the Indian Drug Manufacturers’ Association said the FSSAI had laid down new rules and regulations that were not included in the Food Safety and Standards Act.

“The advisory by the FSSAI to get product approvals for all 80 nutraceutical products and pay Rs 25,000 [US$417] per product was not justified,” Sanghavi said.

“We moved the High Court against FSSAI, and now the court has cancelled the advisory, terming it unlawful.”

TR Gopalkrishnan, secretary-general of the association, added that the advisory would have been particularly hard on small manufacturers.

“For every product to get approved by FSSAI, the nutraceutical manufacturers have to pay Rs 25,000, which is a huge amount.

“Big companies can pay it but what about the small companies who want to come in the market with new product? The High Court’s judgment was in our favour, and we are happy with it.”

Delhi judge threatens jail

Capping a bad week for the FSSAI, the Delhi High Court slammed the authority’s officials for using an export law to “extort” money from traders, and hinted that further breaches of the law would command custodial sentences.

Justice Manmohan hit out at FSSAI staff for asking food importers to pay for the no-objection certificates that Customs officials are required to have before they can release imported food items after their arrival in India.

India’s Food Standards and Safety Act contains a provision to appoint authorised officers to carry out the inspection of imported foods and issue a no-objection certificate or Rejection report (RR) to the Customs department, leading either to the release or confiscation of the imported edibles.

This practice of using the law to line individual profits, had created “undue hassles” and delays, Manmohan said.

The court action came following a petition by United Distributors Incorporation, which had imported a consignment of chocolates from Belgium in January. In it, the company alleged that FSSAI officers had neglected to test or clear the consignment within 24 hours, as they were required to do.

In delivering his judgement, Manmohan said: “If a policeman becomes a terrorist and extortionist, then who will have faith in him? The FSSAI is not understanding my polite way of dealing the matter. I think one officer has to be sent to jail.

“Hearing a food and health matter is not good for my health. I just cannot understand why they are are not testing the sample and releasing the same? How these things will be controlled?”

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Dietary and health supplement manufacturers in India will be breathing a sigh of relief after a decision by the Bombay High Court to quash a controversial advisory by the country’s food regulator concerning prior product approvals.

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